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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tourniquet, Pneumatic
510(k) Number K123553
Device Name ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
Applicant
Zimmer, Inc.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Applicant Contact ALLISON SCOTT, RAC
Correspondent
Zimmer, Inc.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Correspondent Contact ALLISON SCOTT, RAC
Regulation Number878.5910
Classification Product Code
KCY  
Date Received11/19/2012
Decision Date 08/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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